9 CFR 113.304 - Feline Panleukopenia Vaccine.

Feline Panleukopenia Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed Virus.

(a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300 and the requirements prescribed in this section.

(b) The lot of Master Seed Virus shall be tested for other agents as follows:

(1) To detect virulent feline panleukopenia virus or virulent mink enteritis virus, each of two feline panleukopenia susceptible cats, as determined by the criteria prescribed in paragraph (c)(1) of this section, shall be injected subcutaneously with the equivalent of one cat dose each and the cats observed each day for 21 days. If either or both cats show signs of disease or reduced white blood cell counts below 50 percent of the normal level established by an average of three or more counts taken prior to injection, the Master Seed Virus is unsatisfactory.

(i) A constant virus-carrying serum neutralization test in tissue culture using 100 to 300 TCID50 of virus shall be used.

(ii) Cats shall be considered susceptible if there is no neutralization at a 1:2 final serum dilution.

(2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 cats used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five cats held as uninjected controls. To confirm the dosage calculations, five replicate virus titrations shall be conducted on a sample of the vaccine virus dilution used.

(3) Fourteen days post-injection, the vaccinates and the controls shall be challenged with virulent feline panleukopenia virus furnished by Animal and Plant Health Inspection Service and the cats observed each day for 14 days.

(i) If at least 80 percent of the controls do not show clinical signs of feline panleukopenia during the observation period, the test is a No Test and may be repeated. Clinical signs of feline panleukopenia shall include a pronounced leukopenia wherein the white cell count drops to 4,000 or less per cubic mm, or the white cell count drops to less than 25 percent of the normal level established by an average of three or more counts taken prior to challenge.

(ii) If at least 19 of the 20 vaccinates do not survive the observation period without showing clinical signs of feline panleukopenia as described in paragraph (c)(3)(i) of this section, the Master Seed Virus is unsatisfactory.

(4) An Outline of Production change shall be made before authority for use of a new lot of Master Seed Virus shall be granted by Animal and Plant Health Inspection Service.

(d)Test requirements for release. Each serial and subserial shall meet the requirements prescribed in § 113.300 and in this paragraph. Final container samples of completed product shall be tested. Any serial or subserial found unsatisfactory by a prescribed test shall not be released.

(i) Each of two healthy cats shall be injected with 10 cat doses by the method recommended on the label and the cats observed each day for 14 days.

(ii) If unfavorable reactions attributable to the biological product occur during the observation period, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the product, the test shall be declared a No Test and repeated: Provided, That, if not repeated, the serial shall be unsatisfactory.

(2)Virus titer requirements. Final container samples of completed product shall be tested for virus titer using the titration method used in paragraph (c)(2) of this section. To be eligible for release, each serial and each subserial shall have a virus titer sufficiently greater than the titer of vaccine virus used in the immunogenicity test prescribed in paragraph (c) of this section to assure that when tested at any time within the expiration period, each serial and subserial shall have a virus titer of 10
0.7 greater than that used in such immunogenicity test but not less than 10
2.5 TCID50 per dose.

We are amending the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labels for autogenous biologics to specify the organism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, we are also amending the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These changes are necessary in order to update and clarify labeling requirements and to ensure that information provided in labeling is accurate with regard to the expected performance of the product.

We are amending the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms will clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also removing several obsolete testing standard requirements from the regulations. These changes will update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results.

We are amending the “In vitro tests for serial release” regulations by removing a footnote that refers to one method to calculate the relative antigen content of inactivated veterinary biological products and relative potency calculation software available from Veterinary Services' Center for Veterinary Biologics (CVB). CVB will no longer provide or update the software and the written method for using the software will no longer be used. This action will update the regulations.

We will consider all comments that we receive on or before July 29, 2014.

9 CFR Parts 101 and 113

Summary

We are proposing to amend the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms would clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also proposing to remove several obsolete testing standard requirements from part 113. These changes would update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results.